01 1Zhejiang Medicine Co Ltd
01 1MIGLITOL
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-08
Pay. Date : 2012-12-23
DMF Number : 18833
Submission : 2005-01-22
Status : Active
Type : II
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A Glycet manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Glycet, including repackagers and relabelers. The FDA regulates Glycet manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Glycet API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Glycet manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Glycet supplier is an individual or a company that provides Glycet active pharmaceutical ingredient (API) or Glycet finished formulations upon request. The Glycet suppliers may include Glycet API manufacturers, exporters, distributors and traders.
click here to find a list of Glycet suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Glycet DMF (Drug Master File) is a document detailing the whole manufacturing process of Glycet active pharmaceutical ingredient (API) in detail. Different forms of Glycet DMFs exist exist since differing nations have different regulations, such as Glycet USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Glycet DMF submitted to regulatory agencies in the US is known as a USDMF. Glycet USDMF includes data on Glycet's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Glycet USDMF is kept confidential to protect the manufacturer’s intellectual property.
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